- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT01337596
A Study of LY2951742 in Healthy Volunteers
8. října 2018 aktualizováno: Eli Lilly and Company
A Safety, Tolerability, and Pharmacokinetic Study of Single, Escalating Subcutaneous Doses of LY2951742 in Healthy Volunteers
To evaluate the safety and tolerability of LY2951742 given as single or multiple subcutaneous injection in healthy male subjects
Přehled studie
Typ studie
Intervenční
Zápis (Aktuální)
63
Fáze
- Fáze 1
Kontakty a umístění
Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.
Studijní místa
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Leuven, Belgie
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Kritéria účasti
Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.
Kritéria způsobilosti
Věk způsobilý ke studiu
18 let až 55 let (Dospělý)
Přijímá zdravé dobrovolníky
Ano
Pohlaví způsobilá ke studiu
Mužský
Popis
Inclusion Criteria:
- Are healthy Caucasian males, as determined by medical history and physical examination
- Agree to use a reliable method of birth control (e.g. condom AND additional contraception method to be used by respective partner) during the study and for 3 months following the last dose of the investigational product
- Have a body mass index (BMI) greater than 19 kilogram/square meter (kg/m^2)
- Have clinical laboratory test results within normal reference range for the population or investigator site
- Have venous access sufficient to allow for blood sampling
- Are willing to follow study procedures including no drugs (exception of study drug) 72 hours prior to initiation of the laser doppler imaging (LDI) procedure, no chocolate, alcohol or caffeine containing products 12 hours prior to initiation of the laser doppler imaging (LDI) procedure, and complete a 4 hour fast prior to initiation of the laser doppler imaging (LDI) procedure
- Have suitable skin characteristics for the dermal capsaicin challenge and have demonstrated a 100 percent increase in dermal flow following capsaicin challenge as part of the screening procedures and measured by laser doppler imaging (LDI)
Exclusion Criteria:
- Are currently enrolled in, have completed or discontinued within the last 30 days from, a clinical trial involving an investigational product; or are concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study
- Are persons who have previously received the investigational product in this study, have completed or withdrawn from this study investigating LY2951742
- Have an abnormality in the 12-lead electrocardiogram (ECG) that, in the opinion of the investigator, increases the risks associated with participating in the study including QTc greater than 450 milliseconds (msec) (male), history of congenital long QT syndrome or other conduction abnormality
- Have abnormal vital signs as determined by the investigator
- Have a history or presence of significant cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, or neurological disorders (including migraine) that would constitute a risk when taking the study medication; or of interfering with the interpretation of data study
- Regularly use known drugs of abuse and/or show positive findings on urinary drug screening
Show evidence of:
- Human immunodeficiency virus infection and/or positive human immunodeficiency virus (HIV) antibodies
- Hepatitis C and/or positive hepatitis C antibody
- Hepatitis B and/or positive hepatitis B surface antigen
- Intend to use over-the-counter or prescription medication that may interfere with study safety assessments or other measurements within 7 days prior to dosing and during the study (example: systemic glucocorticoids, immunomodulatory drugs, drugs with propensity for dermal reactions, and drugs with known liver toxicity).
- Have donated blood of more than 500 milliliter (mL) or has undergone major surgery
- The use of caffeine containing products and alcohol is not allowed from 12 hours prior to all study visits and during in clinic stays. All other times, alcohol consumption and caffeine intake are limited to no more than 2 alcoholic beverages or equivalent (beer [284 mL/10 ounces], wine [125 mL/4 ounces], or distilled spirits (25 milliliter [mL/1 ounce]) per day and caffeinated beverages will be limited to no more than 2 units per day amounts (1 unit=120 milligrams [mg] of caffeine). Strenuous activity is not allowed from 1 week prior to admission until the follow-up visit.
- Are smokers within the previous 6 months
- Have received treatment with biologic agents (such as monoclonal antibodies) within 3 months or 5 half-lives (whichever is longer)prior to dosing or have received a vaccination within 1 month
- Have a history of multiple or severe allergies or has had an anaphylactic reaction or intolerability to prescription or non-prescription drugs or food
- Are immunocompromised
- Have had cancer or within the past 5 years
- Have a history of significant allergies, in particular to ethanol or sensitivity to the fruits of capsicum plants (example: chili peppers)
- Have eczema, scleroderma, psoriasis, dermatitis, keloids, tumors, ulcers, burns, flaps, or grafts on their forearm or other abnormality of the skin which may interfere with the study assessments
- Cannot avoid excess tanning (any exposure to sunlight or a tanning bed which would cause a sunburn reaction) throughout the study and cannot cover forearms for 24 hours prior to treatment period
- Have excessive hair growth on the volar surface of the forearm or subjects currently using lotions, oils, depilatory preparations, or other topical treatments on a regular basis which cannot be discontinued for the duration of the study; subject has used any topical treatments within 7 days of the start of the study
Studijní plán
Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.
Jak je studie koncipována?
Detaily designu
- Primární účel: Jiný
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Dvojnásobek
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
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Experimentální: Single dose 1 milligram (mg) LY2951742
Administered single subcutaneous injection
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Administered subcutaneously
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Experimentální: Single dose 5 mg LY2951742
Administered single subcutaneous injection
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Administered subcutaneously
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Experimentální: Single dose 25 mg LY2951742
Administered single subcutaneous injection
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Administered subcutaneously
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Experimentální: Single dose 75 mg LY2951742
Administered single subcutaneous injection
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Administered subcutaneously
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Experimentální: Single dose 200 mg LY2951742
Administered single subcutaneous injection
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Administered subcutaneously
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Experimentální: Single dose 600 mg LY2951742
Administered single subcutaneous injection
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Administered subcutaneously
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Komparátor placeba: Single dose placebo
Administered single subcutaneous injection
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Podává se subkutánně
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Komparátor placeba: Multiple dose placebo
Administered subcutaneously every 2 weeks for 6 weeks (4 doses)
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Podává se subkutánně
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Experimentální: 150 mg LY2951742
Administered subcutaneously every 2 weeks for 6 weeks (4 doses)
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Administered subcutaneously
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
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Number of Participants With Clinically Significant Effects
Časové okno: Baseline up to 6 months (study completion)
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Clinically significant effects were defined as serious and other non-serious adverse events (AEs).
A summary of serious and all other non-serious AEs is located in the Reported Adverse Events module.
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Baseline up to 6 months (study completion)
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Sekundární výstupní opatření
Měření výsledku |
Časové okno |
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Single Dose Pharmacokinetics of LY2951742 Maximal Concentration (Cmax)
Časové okno: Day 1 up to Day 84 or early discontinuation
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Day 1 up to Day 84 or early discontinuation
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Single Dose Pharmacokinetics of LY2951742 Area Under the Curve (AUC)
Časové okno: Day 1 up to Day 84 or early discontinuation
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Day 1 up to Day 84 or early discontinuation
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Multiple Dose Pharmacokinetics of LY2951742 Maximal Concentration (Cmax)
Časové okno: Day 43 up to Day 57
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Day 43 up to Day 57
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Multiple Dose Pharmacokinetics of LY2951742 Area Under the Curve (AUC)
Časové okno: Day 43 up to Day 57
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Day 43 up to Day 57
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Spolupracovníci a vyšetřovatelé
Zde najdete lidi a organizace zapojené do této studie.
Sponzor
Termíny studijních záznamů
Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.
Hlavní termíny studia
Začátek studia
1. dubna 2011
Primární dokončení (Aktuální)
1. dubna 2012
Dokončení studie (Aktuální)
1. dubna 2012
Termíny zápisu do studia
První předloženo
15. dubna 2011
První předloženo, které splnilo kritéria kontroly kvality
15. dubna 2011
První zveřejněno (Odhad)
19. dubna 2011
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
20. února 2019
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
8. října 2018
Naposledy ověřeno
1. května 2012
Více informací
Termíny související s touto studií
Klíčová slova
Další identifikační čísla studie
- 14248
- I5Q-MC-CGAA (Jiný identifikátor: Eli Lilly and Company)
Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .